Links
DiaSYS provides services that are compliant with global agencies and reflect current industries practice. Several useful industry links, including organization and specific documents, are listed below.
Canada – Drug and Health products:
Process Validation:
Regulatory Agencies:
- FDA–U.S. Food and Drug Administration
- EMEA–European Medicines Agency
- MHRA–Medicines and Healthcare Products Regulatory Agency (U.K.)
- PMDA-Japan
Organisations:
Documents:
FDA Guides
- FDA: Points to Consider in the Manufacture and Testing. of Monoclonal Antibody Products for Human Use
- FDA Biotechnology Inspection Guide
- FDA’s Guides to Inspections
- FDA: Frequently Asked Questions About Therapeutic Biological Products
Process Validation
Sterile Products
